testXpert III testing software is intuitive and workflow-based.
ZwickRoell will exhibit at the upcoming Pre-Filled Syringes West Coast Conference, June 3-4, at the Crowne Plaza San Diego in Mission Valley, CA, USA. The conference will host a global audience of medical device experts and pre-filled syringe industry leaders to discuss new developments and showcase the latest technologies in the industry.
Visitors to Booth 8 will have the opportunity to demo the zwickiLine single-column solution for the testing of pre-filled syringes to ISO 11040-4. ZwickRoell is the first materials testing machine manufacturer to offer a single solution that tests to the standard, offering interchangeable test fixtures that are ideal for various syringe types to ensure standardized testing.
“Because glass syringes are typically used in connection with injection needles, Luer locks, adapters, and transfer devices, manufacturers are looking for a single solution to perform all of the required tests,” explains Michael Goehring, ZwickRoell in North America’s Medical and Pharmaceutical Industry Manager. “With the zwickiLine testing system and interchangeable tooling, manufacturers are able to perform all ten ISO 11040-4 tests efficiently and accurately on one machine.”
ZwickRoell will also have experts on hand to consult with conference participants on its semi-automated autoinjector, fully automated autoinjector, and pen injector testing solutions. Fully automated solutions range from easy-to-use smart robots only used for feeding and removing the injector to complex robotic systems, which are used to load specimens into multiple testing machines in parallel.
In addition, visitors to Booth 8 can demo testXpert III testing software, which allows for complete, tamper-proof documentation of all actions performed. The user defines the level at which actions are to be logged and explained according to his requirements. In individual cases, this may mean that each change made to a test-relevant parameter, such as test speed, is recorded in full. Together with the user management functions already integrated in testXpert III, this option provides the ideal tool for fulfilling the requirements from FDA 21 CFR Part 11 (regulation of the US Food and Drug Administration). Providing easy access to quality characteristics as well as protection from tampering at the same time allows manufacturers to optimize their processes and sustain improvements in product quality for safety-related products.
For additional information about ZwickRoell solutions for the medical and pharmaceutical industry, visit our website.
Quality assurance in the medical engineering and pharmaceutical industry places the highest demands on testing technology in terms of hardware, software, and documentation. Read more about the various test types and testing machines and systems for the medical engineering industry.
From September 28 through November 26, ZwickRoell will offer 120 online events for the metals, plastics, composites, med/pharm, and automotive industries, as well as for academia and R&D. The Virtual Testing Forum is the first-ever, all-virtual event of this scope and size held specifically for the materials testing industry.
05.10. - 06.10.2020 US - Las Vegas
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Mechanical components in testing machines are usually robustly constructed and perform their duties over many years, even decades. One problem, however, is the fast ongoing development in the areas of electronics and software. ZwickRoell, a leading global supplier of testing machines, provides modernizations not only for ZwickRoell machines, but also for machines from other manufacturers. An example is the modernization of two testing machines from a third-party manufacturer that are used at EndoLab.